MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVFXPLUS-26
Medical Device Problem Codes	Activation Failure (3270); Thickening of Material (4056)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the day following the implant of this transcatheter bioprosthetic aortic valve within a pre-existing non-medtronic transcatheter valve, a computed tomography (ct) was performed.The ct identified a fusiform thickening of the transcatheter aortic valve leaflets.This was consistent with grade 2-3 hypoattenuated leaflet thickening (halt).A transthoracic echocardiogram (tte) was also performed.Baseline medication included anti-coagulation medication.Eliquis and aspirin would continue.The event was reported as resolving.No symptoms occurred due to halt.The physician indicated the event was causal related to the transcatheter valve and the redo transcatheter valve implant procedure.Additional information indicated that prior to the implant of this transcatheter aortic bioprosthetic valve (tav), a pre-implant dilatation of the non-medtronic tav was performed.During the valve-in-valve procedure, the second tav was deployed and underexpansion of the medtronic tav occurred.A post-implant dilatation was performed.
Additional Manufacturer Narrative
D10 ahk continuation of d10: product id {d-evolutfx-2329}; product lot/serial number (b)(6); product type: {delivery catheter system (dcs)}; implant date {na}; explant date {na} product id {l-evolutfx-2329}; product lot/serial number {unknown}; product type: {compression loading system (cls)}; implant date {na}; explant date {na} medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT FX PLUS VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50946641
• Report Number: 9617601-2026-05871
• Device Sequence Number: 9552079
• Product Code: NPT
• UDI-Device Identifier: 00763000716134
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVFXPLUS-26
• Device Catalogue Number: EVFXPLUS-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 11/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 273 LB
• Patient Race: White